Real-World Evidence Webinar Series:
Considerations Regarding Non-Interventional Studies for Drug and Biological Products
Thursday, May 30, 2024 | 2pm-2:45pm (eastern)
The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), is hosting a public webinar as part of a series of webinars for FDA-issued guidance related to real-world evidence (RWE). The latest session in the webinar series will discuss the draft guidance: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.
The draft guidance describes attributes regarding the design and analysis of a non-interventional study, also known as an observational study, that researchers should consider when proposing such a study for regulatory purposes. This guidance provides recommendations to sponsors and investigators who are considering submitting a non-interventional study to the FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of the safety of a drug.
To ensure that the Agency considers comments before working on the final version of this guidance, electronic or written comments on the draft guidance may be submitted to the assigned docket by June 20, 2024; more information on submitting comments to the FDA is available here.
Agenda
2pm |
WelcomeSusan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA |
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2:05pm |
Opening RemarksJohn Concato, MD, MS, MPH, Associate Director for Real-World Evidence Analytics, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
2:10pm |
Overview of Draft GuidanceSpeakers:
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2:25pm |
Question and AnswerModerator: Susan C. Winckler, RPh, Esq. Panelists:
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2:40pm |
Closing RemarksSusan C. Winckler, RPh, Esq. |
2:45pm |
Adjourn |
This webinar is part of a series hosted by the Reagan-Udall Foundation for the FDA, in collaboration with the U.S. Food and Drug Administration (FDA). This series is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $75,417 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit FDA.gov.